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The Genomic Cancer Research Program will provide patients access to customized and targeted therapies, incorporating the unique molecular characteristics of each cancer patient.
Patients who come to Baylor Regional Medical Center at Plano for their surgery may be candidates for participation in the Genomic Cancer Research Program.
Who is Mary Crowley Research Centers? An early phase cancer translational research center headquartered in Dallas, Texas since 1992, having five additional clinical trial sites throughout the U.S. and extensive 20 year experience in use of molecular cancer research therapies.
What is a personalized therapy? A therapy that includes vaccine and gene-targeting agents uniquely engineered to incorporate the molecular characteristics of each cancer patient.
What type of patients are eligible? Phase II clinical testing of the personalized autologous vaccine called FANG™ is currently underway for melanoma patients, with randomized clinical trials open for patients with colon and ovarian cancer. For additional information regarding the criteria for trial participation, contact the nurse navigator, Tricia McCord, RN, OCN.
What does the trial entail? A portion of the patient's cancer tissue, removed during standard of care surgery, is allocated for the manufacture of a targeted triple acting vaccine product that encompasses: antigen education of the patient's immune system to treat tumor cells as foreign, the enhancement of the immune system to increase the production of dendritic cells and the blocking of the enzyme Furin to inhibit the activity of immunosuppressor proteins. The manufacturing process is complete in approximately 4-6 weeks, at which time the patient is evaluated for participation in a clinical trial to receive monthly vaccines for approximately 6-12 weeks.
How many patients have previously participated in this type of clinical trial? A total of 27 patients participated in FANG™ Phase I testing and across all tumor types. Phase II trials are currently enrolling.
What were the previous trial results? Phase I trial results exhibited safety, prolonged disease stabilization and increased survival time. Results published in Molecular Medicine/online, December 20th, 2011.
What is the role of the surgeon? 1. Remove a pea size amount of normal tissue from any cancer type and a grape size amount of cancer tissue; the required amount for genomic research and submission to the Texas Cancer Research Biorepository*.
2. Remove the equivalent of a golf ball size tumor (5g) mass; the necessary amount for adequate vaccine preparation.
A tissue procurement technician within the operating suite at Baylor Regional Medical Center at Plano will collect the tissues and arrange for their transfer to Gradalis Inc. in Carrollton, Texas for vaccine manufacturing and to the Texas Cancer Research Biorepository* for molecular research.
Where will the clinical trials be conducted after the vaccine is manufactured? Clinical trials will be conducted at the Mary Crowley Research Center located at 7777 Forest lane, Dallas, Texas 75230.
Who do I contact for more information? Nurse Navigator, Tricia McCord, RN, OCN at (469)814-4417 or firstname.lastname@example.org.
*Located in Houston, Texas, the Texas Cancer Research Biorepository is a Texas wide cancer tissue repository for the purpose of advancing collaborative research among academic scientists investigating molecular profiles of cancer and normal cells; needed to rapidly translate scientific advances from the laboratory to the patient.
Baylor Regional Medical Center at Plano and Mary Crowley Cancer Research Center are not affiliated. Each reviews, approves, and conducts clinical trials independently.
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